NesinaTreatment for Diabetes Type 2
Update: Nesina (alogliptin) Now FDA Approved - January 25, 2013
Complete Response Letter for Alogliptin
Takeda Receives FDA Complete Response Letter for Alogliptin, an Investigational Treatment for Type 2 Diabetes
DEERFIELD, Ill., June 26, and OSAKA, Japan, June 27, 2009 /PRNewswire/ -- Takeda Pharmaceutical Company Limited ("Takeda") today announced that Takeda Global Research & Development Center, Inc., a wholly owned United States (U.S.) subsidiary received on June 26 (U.S. time) a complete response letter from the U.S. Food and Drug Administration (FDA) regarding the Company's New Drug Application (NDA) for alogliptin, a selective dipeptidyl peptidase IV (DPP-4) inhibitor under investigation for the treatment of type 2 diabetes as an adjunct to diet and exercise. In recent months, the FDA and Takeda have been in discussions about conducting an additional cardiovascular study for alogliptin.
As previously announced on March 6, 2009, the FDA informed Takeda that, although the alogliptin NDA was filed prior to the release of the December 2008 FDA Guidance titled, "Guidance for Industry: Diabetes Mellitus -- Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes," the FDA did not believe that the amount of existing alogliptin clinical data was sufficient to meet certain statistical requirements outlined in that Guidance. The FDA has asked Takeda to conduct an additional cardiovascular safety trial that satisfies the December 2008 FDA Guidance.
"Takeda will continue to promote key initiatives in order to realize sustained growth from a medium- to long-term perspective," said Takeda President & CEO, Yasuchika Hasegawa.
About Takeda Pharmaceutical Company Limited
Located in Osaka, Japan, Takeda is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to striving toward better health for individuals and progress in medicine by developing superior pharmaceutical products. Additional information about Takeda is available through its corporate Web site, www.takeda.com.
About Takeda Pharmaceuticals North America, Inc. and Takeda Global Research & Development Center, Inc.
Based in Deerfield, Ill., Takeda Pharmaceuticals North America, Inc. and Takeda Global Research & Development Center, Inc. are subsidiaries of Takeda Pharmaceutical Company Limited, the largest pharmaceutical company in Japan. The respective companies currently market oral diabetes, insomnia, rheumatology and gastroenterology treatments and seek to bring innovative products to patients through a pipeline that includes compounds in development for diabetes, cardiovascular disease, gastroenterology, neurology and other conditions.
Posted: June 2009
- Takeda Receives FDA Approval for Nesina (alogliptin) for Type 2 Diabetes - January 25, 2013
- Takeda Resubmits New Drug Applications to the United States Food and Drug Administration for Alogliptin and the Fixed-Dose Combination Alogliptin and Pioglitazone - July 27, 2012
- Takeda Receives Complete Response Letter from the FDA for Type 2 Diabetes Investigational Therapies Alogliptin and Fixed-Dose Combination Alogliptin and Pioglitazone - April 27, 2012
- Furiex Confirms Takeda's Receipt of Complete Response Letter from the FDA for Alogliptin and Fixed-Dose Combination Alogliptin and Pioglitazone - April 26, 2012
- U.S. Food and Drug Administration (FDA) Delays Review of Takeda's Investigational Type 2 Diabetes Therapies, Alogliptin and Alogliptin/Pioglitazone - November 18, 2011
- Takeda Announces PDUFA Action Date for Investigational Type 2 Diabetes Therapies Alogliptin and the Fixed-Dose Combination Alogliptin/Pioglitazone - November 1, 2011
- Takeda Resubmits New Drug Applications in the U.S. for Investigational Type 2 Diabetes Therapies Alogliptin and the Fixed-Dose Combination Alogliptin/Pioglitazone - July 26, 2011
- Takeda Initiates Cardiovascular Outcomes Trial for Alogliptin, An Investigational Treatment for Type 2 Diabetes - August 28, 2009
- Takeda Receives New Information on Alogliptin (SYR-322) NDA - March 6, 2009
- Takeda Receives New Action Date for Alogliptin (SYR-322) NDA - December 24, 2008
- FDA Continues Review of Takeda's New Drug Application for Alogliptin (SYR-322), a DPP-4 Agent for Type 2 Diabetes - October 10, 2008
- PPD Confirms Takeda's NDA Filing of Alogliptin with U.S. Food and Drug Administration - February 29, 2008
- Takeda Submits New Drug Application for Alogliptin (SYR-322) in theU.S. - January 4, 2008
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